Liver CirrhosisSECCINCT00763776
Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector
A study testing clamp crushing technique and ultrasonic dissector in people with Liver Cirrhosis and Liver Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector. Primary endpoint is intra-operative blood loss during liver transection (ml). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular
- What is being tested?
- clamp crushing technique and ultrasonic dissector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child A liver cirrhosis
- Partial hepatectomy (≥ 1 segment).
- Patient at least 18 years of age
Who cannot join
- Non cirrhotic patient
- Child B or C cirrhosis
- Portal hypertension
- Laparoscopic hepatectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.
To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector.
Primary endpoint is intra-operative blood loss during liver transection (ml). Expected results and implications: If one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.
Read the detailed description
Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. The trial will last 24 months with 21 month-inclusion time.
Patients Patients will be enrolled in 5 university hospitals in Ile de France. Eligibility criteria include adults with Child A liver cirrhosis undergoing partial hepatectomy (≥ 1 liver segment). Exclusion criteria include non cirrhotic patients, Child B or C cirrhosis, portal hypertension and laparoscopic hepatectomy.
Sample size calculation was performed with the expectation of a 250 ml (one red cells pack) difference in blood loss during parenchyma transection with a level of statistical significance of 0.05 and a power of 0.80. These calculations indicated to include at least 60 patients in each group.
Secondary endpoints include blood loss standardized to the transection area (ml/cm²), free margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative complications.
Course of the study An informed consent will be obtained from each patient prior to surgery. Each patient will be randomized the day prior to surgery. As usual, each patient will be followed daily until he will discharge (10 days) and for 2 months at the postoperative outcome patient clinic, which will end the study period for the patient.
- Conditions
- Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular
- Being tested
- clamp crushing technique, ultrasonic dissector
- Keywords
- Liver cirrhosis, Hepatectomy, Liver parenchyma transection, Randomized controlled trial
- Medical subject headings
- Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clamp crushing techniqueDevice
Liver transection during hepatectomy by clamp crushing technique
ultrasonic dissectorDevice
Liver transection during hepatectomy by the ultrasonic dissector
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Liver transection by clamp crushing technique Receives: Device: clamp crushing technique |
| 2 | Other | Liver transection by the ultrasonic dissector Receives: Device: ultrasonic dissector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative blood loss during liver transection (ml).
Measured: during liver transection
Secondary outcomes (4)
Intra-operative blood loss standardized to the transection area (ml/cm²)
Measured: during liver transection
free margins around the tumor
Measured: during liver transection
postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)
Measured: daily until the discharge of the patient
60-day postoperative complications
Measured: 2 months after the liver transection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: difficulty for the patient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael LESURTEL, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763776
- Sponsor's protocol ID
- K070105
- Acronym
- SECCI
- Status last verified
- Jan 2011
- First submitted
- 30 Sep 2008
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT00763776
- Acronym / sponsor ID
- SECCI / K070105
- Conditions
- Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular
- Keywords
- Liver cirrhosis, Hepatectomy, Liver parenchyma transection, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty for the patient recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector.
Primary endpoint is intra-operative blood loss during liver transection (ml). Expected results and implications: If one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.
Detailed description
Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. The trial will last 24 months with 21 month-inclusion time.
Patients Patients will be enrolled in 5 university hospitals in Ile de France. Eligibility criteria include adults with Child A liver cirrhosis undergoing partial hepatectomy (≥ 1 liver segment). Exclusion criteria include non cirrhotic patients, Child B or C cirrhosis, portal hypertension and laparoscopic hepatectomy.
Sample size calculation was performed with the expectation of a 250 ml (one red cells pack) difference in blood loss during parenchyma transection with a level of statistical significance of 0.05 and a power of 0.80. These calculations indicated to include at least 60 patients in each group.
Secondary endpoints include blood loss standardized to the transection area (ml/cm²), free margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative complications.
Course of the study An informed consent will be obtained from each patient prior to surgery. Each patient will be randomized the day prior to surgery. As usual, each patient will be followed daily until he will discharge (10 days) and for 2 months at the postoperative outcome patient clinic, which will end the study period for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: clamp crushing techniqueLiver transection by clamp crushing technique |
| 2 | Other | Device: ultrasonic dissectorLiver transection by the ultrasonic dissector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Child A liver cirrhosis
- Partial hepatectomy (≥ 1 segment).
- Patient at least 18 years of age
Key exclusion criteria (4 listed)
- Non cirrhotic patient
- Child B or C cirrhosis
- Portal hypertension
- Laparoscopic hepatectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clamp crushing techniqueLiver transection during hepatectomy by clamp crushing technique | Device | 1 |
| ultrasonic dissectorLiver transection during hepatectomy by the ultrasonic dissector | Device | 2 |
Primary outcome
Intra-operative blood loss during liver transection (ml).
Time frame: during liver transection
4 secondary outcomes
Intra-operative blood loss standardized to the transection area (ml/cm²)
Time frame: during liver transection
free margins around the tumor
Time frame: during liver transection
postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases)
Time frame: daily until the discharge of the patient
60-day postoperative complications
Time frame: 2 months after the liver transection
Results and safety
The study was stopped early (reason given: difficulty for the patient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mickael LESURTEL, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clamp crushing technique and ultrasonic dissector in people with Liver Cirrhosis and Liver Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty for the patient recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative blood loss during liver transection (ml). (time frame: during liver transection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.